FDA’s UDI Initiative Continues to Roll Forward
With the close of the 7th Annual UDI Conference in Baltimore late last month, FDA took another big step forward in providing an electronic library of medical device information. During the conference, FDA shared a number of milestones completed in the last eight months since the previous conference.
Linda Sigg, FDA’s Associate Director of Informatics, shared that since the last conference held in October 2014 there has been quite a lot of progress made by her UDI group as well as the Medical Device community. In these past eight months, the number of Device Identification records in the GUDID increased from 33,000 to over 75,000. The number of manufacturer/labeler accounts grew from 240 to 425 accounts and FDA’s UDI Help Desk inquiries doubled to over 8,000 with an increase in their closure rate from 91% to 95%.
This growth was primarily due to the second group of devices requiring to meet FDA compliance due dates by September 24, 2015: those devices classified as implantable, life-saving, and life-sustaining.
Also accomplished during this time frame was the launch of the “AccessGUDID” website for public searching and downloading of the “GUDID” repository, finally allowing the fruits of all this collection of data to be visible to the healthcare community, at least for devices currently required to comply.
Mrs. Sigg also announced that upcoming capabilities to watch for was an advanced searching capability within the AccessGUDID system, as well as the implementation and availability of web services for external access to the GUDID. Ostensibly, the web services function will allow labelers/manufacturers and 3rd party vendors to actively integrate and search/download information electronically from the GUDID without the use of the AccessGUDID interface.
As the manufacturers/labelers of implantable, life-saving, and life-sustaining devices get closer to their due date for labeling and GUDID submissions this year, the next group of manufacturers/labelers: Class II devices (that are not implantable, life-saving, and life-sustaining) come to the plate. Accounts and GUDID access for these manufacturers/labelers will start being processed and made available in January of 2016 so as to help this group meet their labeling and GUDID submission compliance date of September 24, 2016. Following this September milestone, the information available in the GUDID will increase substantially. Soon after this milestone, Class I and unclassified devices will have their turn to begin labeling and submitting UDI information to the FDA, in order to meet their compliance date of September 24, 2018.
Also during the conference, guidance on the direct marking of devices was released, and for those devices requiring direct marking (e.g. the device is intended to be used more than once and intended to be reprocessed before each use) there are specific compliance due dates as well. These are posted on the FDA UDI website.
If your business manufactures Class II or Class I devices, be ready to get involved soon. Start planning now, if you haven’t already done so. Don’t wait until FDA grants your company access in order to begin to plan out how you will be compliant in your labeling of your devices, including direct marking (if applicable), as well as planning how to best manage and electronically submit your device’s UDI information to the GUDID system.